Triton 1.5 Robotic System for Diagnostic Colonoscopy (CARE II)

Initial Clinical Experience With the Triton 1.5 Robotic System for Diagnostic Colonoscopy

This study is a prospective, single-arm, non-randomized, single-site study, focused on evaluating the safety and efficacy of the Triton 1.5 System in diagnostic and basic therapeutic colonoscopy.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Neoplasms; Colonoscopy; Gastrointestinal Endoscopy; Colorectal Cancer Screening
• Intervention / Treatment: Device: Diagnostic Test: Diagnostic Colonoscopy

Detailed Description

This study is a prospective clinical investigation designed to evaluate the safety, and efficacy of the Triton 1.5 System in performing diagnostic, screening, surveillance, and basic therapeutic tasks (e.g., polypectomy for lesions ≤ 2cm). Up to 40 subjects will undergo robotic colonoscopy using the Triton 1.5 System with three operating physicians.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hayley Holm; Phone Number: (650) 922-5512; Email: hayley.holm@neptunemedical.com
• Study Contact Backup: Name: Min-Sun Son; Phone Number: (650) 714-1803; Email: minsun@neptunemedical.com

Study Locations

• Poland
  • Silesian Voivodeship
    • Tychy, Silesian Voivodeship, Poland, 43-100
      • HT Centrum Medyczne
      • Sub-Investigator: Marcin Romanczyk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Age ≥ 22 years
2. Adults indicated for elective screening, surveillance or diagnostic colonoscopy
3. Subject is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures
4. Subject is willing and able to comply with all protocol required preparation and follow- up visits

Exclusion Criteria:

1. Any medical or physical condition/limitation that would contraindicate a conventional colonoscopy. This assessment will be made by the investigator.
2. Any active or magnetic implantable medical devices (e.g., pacemakers, defibrillators)
3. Previous failed colonoscopy (except for inadequate bowel preparation)
4. BMI > 45 kg/m2
5. Pregnant participants, women of reproductive potential (pre-menopausal and/or no history of hysterectomy), confirmed by a positive pregnancy test (serum).
6. Surgically altered colonic anatomy
7. History of colorectal cancer, inflammatory bowel disease, polyposis syndrome, hereditary nonpolyposis colorectal cancer (Lynch) syndrome, sclerosing encapsulating peritonitis, active diverticulitis in last 6 months or toxic megacolon
8. Lower gastrointestinal bleeding within 28 days prior to the colonoscopy day
9. Known bleeding tendency such as hemophilia or coagulation factor deficiencies
10. Subject receiving antiplatelet or anticoagulation therapy apart from low-dose aspirin
11. Known colonic stricture
12. Known risk factors for abdominal adhesions such as history of complex abdominal or pelvis surgical procedures, based on investigator assessment
13. Known abdominal wall hernias
14. History of radiotherapy to the abdomen or pelvis
15. History of mesenteric ischemia
16. Known coronary ischemia or cardiovascular stroke within 3 months prior to the colonoscopy procedure
17. Contraindication to the proposed sedation / anesthesia
18. Received any investigational medicine or treatment within 28 days prior to the colonoscopy procedure
19. Received or planning to receive any other endoscopic procedure within 4 weeks prior and 2 weeks after the colonoscopy procedure
20. Participation in any concurrent clinical trial that may impact the results of this study

Intra-Operative Criteria:

1. Inadequate bowel preparation, defined as a Boston Bowel Preparation Scale (BBPS) (Appendix A) score < 2 in any segment.
2. Any intraoperative finding or condition that, in the Investigator's judgment, would make study participation unsafe or not in the subject's best interest (e.g., significant stricture, tight sigmoid colon precluding safe overtube passage).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single Arm; This study is a prospective, single-arm, non-randomized, single-site study, which is deigned to evaluate the safety and efficacy of the Triton 1.5 System for performing diagnostic, screening, surveillance, and basic therapeutic tasks (e.g., polypectomy for lesions ≤2cm) during endoscopic procedures.	Device: Diagnostic Test: Diagnostic Colonoscopy; This study will serve to evaluate the safety and efficacy of the Triton 1.5 System for performing diagnostic, screening, surveillance, and basic therapeutic tasks (e.g., polypectomy for lesions ≤2cm).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Safety Endpoint - Incident of Major Adverse Events within 48 Hours	Absence of Major Adverse Events (MAEs) within 48 hours of the procedure. MAEs are defined as the following: (a) Device-related death within 48 hours, (b) Perforation within 48 hours, (c) Intraprocedural bleeding preventing completion of the procedure, (d) Delayed bleeding within 48 hours accompanied by predefined symptoms and confirmed by a hemoglobin drop of >2 g, as applicable, leading to admission to hospital, prolongation of existing hospital stay, another procedure (requiring sedation/anesthesia). Unit of Measure: Number of participants with at least one Major Adverse Event	48 Hours
Primary Efficacy Endpoint - Successful Completion of Colonoscopy During Procedure	Completion of colonoscopy defined by both: (a) Successful cecal intubation with visualization of the appendiceal orifice, (b) Successful withdrawal with clinically acceptable diagnostic inspection and therapeutic access.	During Procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Safety Endpoint - Mucosal Injury Score During Procedure	Mucosal Injury graded using a visual assessment of the colonic wall during withdrawal of the procedure using the following scale: (1) Erythema / Bruising, (2) Mucosal break < 5 mm, (3) Mucosal break > 5 mm, (4) Muscle injury (non-full thickness), (5) Full-thickness injury. Unit of Measure: Score (1-5), higher scores indicate more severe injury	During Procedure
Secondary Safety Endpoint - Delayed Bleeding Within 14 Days	Delayed bleeding within 14 days, defined as: bleeding within 48 hours accompanied by pre-defined symptoms and confirmed by a hemoglobin drop > 2 g, leading to admission to hospital, prolongation of existing hospital stay, another procedure (requiring sedation/anesthesia).	14 days post-procedure
Secondary Safety Endpoint - Delayed Perforations Within 14 Days	Delayed perforations within 14 days, defined as: perforations occurring within 14 days post-procedure.	14 days post-procedure
Secondary Efficacy Endpoint - Time to Cecum During Procedure	Interval from nested-system insertion at the anal verge to first visualization of the appendiceal orifice. Pauses for ancillary or therapeutic tasks (e.g., biopsy, polypectomy ≤ 2 cm, repositioning, prolonged washing) are recorded and subtracted to isolate insertion performance. For polypectomy pauses, time is measured from first polyp visualization to confirmation of retrieval in the specimen trap. Unit of Measure: Minutes or seconds	During Procedure
Secondary Efficacy Endpoint - Need for Repositioning During Procedure	Number of times a participant was repositioned during the procedure. Unit of Measure: Number of repositioning events	During Procedure
Secondary Efficacy Endpoint - Polypectomy Success During Procedure	Clinically acceptable polypectomy performed with cold forceps, cold snare, or hot snare leaving no visible residual polyp. Polyps > 2 cm or lesions too complex for diagnostic colonoscopy are excluded and deferred for later advanced therapy.	During Procedure
Secondary Efficacy Endpoint - NASA Task Load Index (NASA-TLX) Post-Procedure	Physician's subjective workload assessment using the NASA Task Load Index (NASA-TLX), a validated tool consisting of six subscales: Mental Demand, Physical Demand, Temporal Demand, Performance, Effort, and Frustration. Each subscale is scored from 0 to 100 in increments of 5. Higher scores indicate greater perceived workload. Unit of Measure: Composite score (0-600)	Immediately after Procedure
Secondary Efficacy Endpoint - Adenoma Detection Rate During Procedure	Percentage of subjects with ≥ 1 histologically confirmed adenoma or carcinoma Unit of Measure: Percentage of participants	During Procedure

Collaborators and Investigators

• Sponsor: Neptune Medical
• Collaborators: H-T. Centrum Medyczne Sp. z o.o. sp. k; KCRI
• Investigators: Principal Investigator: Marcin Romanczyk, MD, H-T Centrum Medyczne

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 15, 2026

Study Registration Dates

• First Submitted: May 11, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: CP-000005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No